ISMP Probe: Chantix Suicides Underreported by Pfizer

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According to a new study, Pfizer has failed to report adverse psychiatric problems associated with its smoking cessation drug Chantix for years. Pfizer’s failure to comply with federal regulations has subsequently resulted in a huge underestimation of the dangers posed by the drug. Among the previously unreported statistics were at least 150 Chantix suicide reports, which more than tripled the number of known suicides linked to the drug.

What’s the problem?

May 20, 2011 – In a quarterly report submitted this week to the U.S. Food & Drug Administration (FDA), the Institute for Safe Medicine Practices (ISMP) indicated that Pfizer has failed to properly file hundreds of adverse event reports involving psychiatric problems linked to its anti-smoking drug Chantix since 2006. The new findings have prompted ISMP to call for a federal investigation into Pfizer’s actions.

The number of adverse events associated with Chantix outnumber any other medication monitored by the nonprofit organization, and include reports of suicide, depression, psychological side effects and violence. More than twice as many deaths have been linked to Chantix than with any other medication currently on the U.S. market.

The ISMP noticed a peculiar spike of adverse events reported for Chantix in the third quarter of 2010, including 559 reports of serious Chantix side effects and deaths that occurred years ago but were never reported. FDA regulations require pharmaceutical companies to file serious reports to the Adverse Events Reporting System (AERS) within 15 days of receiving them.

In 2009, the FDA required a ‘black box’ warning – the strictest warning allowed by law – to be added to the packaging of Chantix alerting consumers about the risk of suicide and psychological side effects that have been linked to the product. Last year, the administration sent a warning letter to Pfizer stating that since 2004 it had repeatedly failed to submit serious reports, misclassified other reports, and downgraded serious problems into non-serious reports.

Chantix Side Effects

Chantix has been linked to serious mental health events including:

  • severe behavioral changes
  • depressed mood
  • hostility
  • aggression
  • suicidal idealization
  • suicide

Other less severe Chantix side effects include:

  • drowsiness
  • nausea
  • vomiting
  • headaches
  • difficulty falling asleep
  • psychosomatic illness
  • radical alterations in dreams

Chantix Lawsuits

On May 9, 2011, a lawsuit was brought against Pfizer over a high profile Chantix murder-suicide case in Pennsylvania. The claim was filed on behalf of Sean and Natalie Wain in the U.S. District Court for the Western District of Pennsylvania, and claims that Pfizer failed to adequately research chantix and warn about the risk of possible violent side effects. According to the complaint, Mr. Wain had been using Chantix for less than two weeks when he began to experience psychotic fits of rage that ultimately led him to shoot his wife and kill himself. This latest claim is part of an alarming trend of over 100 Chantix lawsuits filed in courts throughout the United States on behalf of individuals who died or were injured as a result of the medication.

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